Device and method for aortic branched vessel repair

ABSTRACT

An aortic graft assembly includes a tubular component that defines a wall aperture having a proximal end that extends perpendicular to a major longitudinal axis of the tubular aortic component, and a tunnel graft connected to the wall of the tubular aortic component and extending from the wall aperture toward a proximal end of the tubular aortic component. The method for delivery of the aortic graft assembly includes delivering the aortic graft assembly through the wall aperture and into interferring relation with the tunnel graft.

RELATED APPLICATIONS

This application is a continuation of International Application No.PCT/US2012/065622, filed on Nov. 16, 2012, which claims the benefit ofU.S. Provisional Application No. 61/560,517, filed on Nov. 16, 2011. Theentire teachings of the above applications are incorporated herein byreference.

BACKGROUND OF THE INVENTION

Aortic aneurysms are life-threatening conditions. Surgical interventionsused to treat aortic aneurysms include endovascular repair bytransluminal placement of one or more endografts across the longitudinalextent of the lesion. The endograft is placed in the aorta with theintention of bridging the aneurysmal sac to exclude it from thehigh-pressure of aortic blood flow, which can permit remodeling of theaortic wall in and around the aneurysm site. In certain regions of theaorta accurate placement of the endograft is critical to maintain bloodflow to vessels branching from the aorta to minimize compromised bloodflow to organs. For example, currently, if aortic devices are placedwithin the aortic arch in a manner that offsets the aperture for theleft carotid artery, the artery can be occluded, which can result inischemia to the brain. Most surgical methods of treating aneurysms at ornear the aortic arch generally involve sternotomy or thoracotomy and mayrequire cardio-pulmonary bypass, often resulting in high morbidityrates. Thus, there is a need to develop new and useful devices andmethods of treating aortic aneurysms by endovascular methods.

SUMMARY OF THE INVENTION

The present invention relates to vascular repair systems, deliverysystems and methods of using the delivery systems and its components totreat aortic vascular damage, in particular, vascular damage associatedwith aortic disease, such as, aneurysms, penetrating atheroscleroticulcers and dissection.

In an embodiment, the invention is an aortic graft assembly thatincludes a tubular aortic component having a proximal end and a distalend connected by a wall of the tubular aortic component, the walldefining a wall aperture that is between the proximal and distal ends.The aperture has a proximal end that extends perpendicular to a majorlongitudinal axis of the tubular aortic component when viewedorthogonally to the major longitudinal axis. A tunnel graft is connectedto the wall of the tubular aortic component and extends from the wallaperture toward the proximal end of the tubular aortic component. Thetunnel graft has a proximal end and a distal end, the distal end beingat the wall aperture of the tubular aortic component. A proximal stentabuts the proximal end of the aperture, and a distal stent abuts adistal end of the aperture.

In yet another embodiment, the invention is an aortic graft assembly,comprising a tubular aortic component that includes a proximal end and adistal end connected by a wall of the tubular aortic component, the walldefining a wall aperture that is between the proximal and distal ends,the wall aperture having a proximal end and a distal end, the proximalend of the wall aperture extending perpendicular to a major longitudinalaxis of the tubular aortic component when viewed orthogonally to themajor longitudinal axis; a tunnel graft connected to the wall of thetubular aortic component and extending from the wall aperture toward theproximal end of the tubular aortic component, the tunnel graft having aproximal end and a distal end, the distal end being at the wall apertureof the tubular aortic component; a proximal stent that supports theproximal end of the tubular aortic component; a distal stent thatsupports the distal end of the tubular aortic component; a claspingstent at the proximal end of the tubular aortic component, the claspingstent including at least two exposed proximal apices proximate to theproximal end of tubular component and attached to an interior wall ofthe tubular aortic component; and a crown stent between the claspingstent and the proximal end of the tubular aortic component, the crownstent attached to an interior surface of the tubular aortic component.

In a further embodiment, the invention is an aortic graft assembly,comprising a tubular aortic component that includes a proximal end and adistal end connected by a wall of the tubular aortic component, the walldefining a wall aperture that is between the proximal and distal ends,the wall aperture having a proximal end and a distal end, the proximalend of the wall aperture extending perpendicular to a major longitudinalaxis of the tubular aortic component when viewed orthogonally to themajor longitudinal axis; a tunnel graft connected to the wall of thetubular aortic component and extending from the wall aperture toward theproximal end of the tubular aortic component, the tunnel graft having aproximal end and a distal end, the distal end being at the wall apertureof the tubular aortic component; a proximal stent that abuts theproximal end of the tubular aortic component; a distal stent thatsupports the distal end of the tubular aortic component; an abuttingdistal stent that includes at least one proximal apex that abut thedistal end of the wall aperture; a clasping stent at the proximal end ofthe tubular aortic component, the clasping stent including at least twoexposed proximal apices proximate to the proximal end of tubularcomponent and attached to an interior wall of the tubular aorticcomponent; and a crown stent between the clasping stent and the proximalend of the tubular aortic component, the crown stent attached to aninterior surface of the tubular aortic component.

In another embodiment, the invention is a method for implanting aprosthesis, including delivering a tubular aortic component defining awall aperture through an aorta of a patient to an aneurysm site of thepatient, the tubular aortic component being radially and releasablyconstrained by a distal clasp at a distal end of an outer control tubeof a delivery device, and releasably attached by a retention componentto a proximal clasp at the outer control tube proximal to the proximalclasp, the tubular aortic component further supported by a controlcatheter of the delivery device extending within the outer control tube.The wall aperture is aligned over at least one vessel ostium at theaneurysm site of the patient. The outer tube is retracted, therebyreleasing the tubular aortic component from the distal and proximalclasps, thereby deploying the tubular aortic component at the aneurysmsite.

In an additional embodiment, the invention is a method for implanting aprosthesis, comprising the steps of delivering a tubular aorticcomponent defining a wall aperture through an aorta to an aneurysm siteof a patient, the tubular aortic component being radially and releasablyconstrained by a distal clasp at a distal end of an outer control tubeof a delivery device, and releasably attached by a retention componentto a proximal clasp at the outer control tube proximal to the proximalclasp, the tubular aortic component further supported by a controlcatheter of the delivery device extending within the outer control tube;aligning the wall aperture over at least one vessel ostium at theaneurysm site of the patient; retracting the outer control tube, therebyreleasing the tubular aortic component from the distal and proximalclasps, thereby deploying the tubular aortic component at the aneurysmsite in the patient, wherein at least one supporting wire extends fromthe control tube, said supporting wire extending through a suture loopinside the proximal end of the tubular aortic component to therebyprevent collapse of the proximal end of the tubular component duringdeployment. The method can further includes the step of partiallyretracting an inner sheath from around the tubular aortic component,whereby the supporting wire at least partially restricts longitudinalmovement of the proximal end of the tubular aortic component until theproximal end of the tubular aortic component is secure within the aorta,to thereby prevent collapse of the proximal end of the tubular aorticcomponent at an inferior portion of the aorta, wherein the inner sheathis releasably secured to a distal end within a cavity defined by aproximal end of the nose cone, wherein the steps of the method includepartially retracting an inner sheath from around the tubular aorticcomponent to release the distal end of the inner sheath from the nosecone and thereby cause partial deployment of the tubular aorticcomponent; partially retracting the control catheter to thereby releasethe clasping stent from the distal apex clasp and the retentioncomponent from the proximal clasp; further retracting the controlcatheter to at least partially retract the nose cone to within thetubular aortic component while retaining the suture loops on thesupporting wires; advancing the tubular aortic component to a finalposition in the aorta of the patient spanning the aneurysm; fullyretracting the inner sheath from the tubular aortic component; and fullyretracting the nose cone and supporting wires to release the sutureloops from the supporting wires, thereby fully deploying the tubularaortic component within the aorta of the patient.

In an embodiment, a stent defining the aperture permits blood flow intothe ostium of the target vessel, unlike other systems that rely on anarrowing or dog-bone shape of the body of the tubular aortic componentof an aortic graft system to permit blood flow outside and around thetubular graft component if the surgeon is unable to align the aperturewith the ostium of the target vessel.

The aortic graft assembly of the invention does not require preciseradial or longitudinal alignment in the aorta and permits approximatealignment, which is beneficial in reducing the manipulation of theaortic arch and resulting stroke in the patient. The claimed systems canbe fully deployed before the surgeon completes the endovascularprocedure by deployment of the first tunnel or second tunnel graft,unlike current aortic components that are in a “dogbone” configurationto guard against unintentional obstruction of the target ostium. Thedelivery device employed with the graft assembly aids in properalignment of the assembly in the aorta by, for example, use of a curvedguidewire catheter, proximal clasp and distal clasp.

The aortic assembly systems and methods of the invention can be employedto treat aortic aneurysms, such as aortic aneurysms at, near or aroundthe arch of the aorta, or branches from the abdominal aorta (e.g.,celiac artery, superior mesenteric artery and renal arteries). Theaortic assembly systems of the invention have a relatively largeaperture tapered into a tunnel graft that provides the surgeon with arelatively large margin of error in placement of the system, facilitatescanulation and permits alignment of a single aperture for at least oneblood vessel. Aortic assembly systems of the invention that include atunnel graft having one aperture extending proximally with two openingspermit for easy alignment in the aorta, particularly in regions of theaorta that branch to peripheral and major vessels. The size of theaperture allows blood to flow to target vessels during the procedure.The aortic graft assembly of the invention generally does not restrictblood flow acutely or chronically, in part, because of a relativelylarge diameter of the tunnel graft and the stent or stents supportingthe tunnel graft.

Barbs in the interior of the tunnel grafts of the branched graftassembly have the advantage of securing connection of the tubularcomponent to the tunnel graft. The telescoping ability of the graftassembly systems of the invention, for example, the length and differentconfigurations of the tunnel graft, allow the tubular component to bepositioned in-situ to ensure maximum use of a “landing zone” inside thetarget vessel. A relatively long tunnel length can ensure adequateoverlap with the tubular component into the tunnel grafts to ensure asufficient seal.

The delivery device of the invention also has the advantage of allowingthe proximal end of the stent graft to be aligned perpendicular to thecenter line axis of the “landing zone.” This is of key concern when thelanding zone is in Zone 0 (FIGS. 15, 16, 17) of the ascending aorta.When landing in this area much care must be taken to avoid accidentalcoverage of the coronary arteries, typically the left coronary artery.

Thus, the aortic graft assembly, delivery systems, and methods of theinvention can be used to treat various aortic pathologies, includingaortic aneurysms, penetrating atherosclerotic ulcers, dissections and,therefore, avoid complications and death consequent to life-threateningvascular conditions.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A, 1B and 1C represent an embodiment of an aortic assembly systemof the invention.

FIGS. 2A and 3A represent cross sectional views of the aortic assemblysystem of the invention, shown in FIG. 1A, taken along line 2A.

FIGS. 2B and 3B represent a longitudinal view of FIGS. 2A and 3A of anaortic assembly system of the invention.

FIGS. 4A and 4B represent embodiments of an aortic assembly system ofthe invention, taken from views 4A and 4B of FIGS. 2A and 2B.

FIG. 5 is a perspective view into the proximal end of one embodiment ofthe invention.

FIG. 6 represents another embodiment of an aortic assembly system of theinvention.

FIGS. 7A and 8A represent additional embodiments of an aortic assemblysystem of the invention.

FIGS. 7B and 8B represent additional embodiments of an aortic assemblysystem of the invention taken along lines 7B and 8B of FIGS. 7A and 8A,respectively.

FIGS. 9A and 10A represent additional embodiments of an aortic assemblysystem of the invention.

FIGS. 9B and 10B represent further embodiments of an aortic assemblysystem of the invention taken along lines 9B and 10B of FIGS. 10A and10B, respectively.

FIG. 11 is a perspective view of one embodiment of an aortic assemblysystem of the invention mounted on one embodiment of a delivery systemof the invention.

FIG. 12 represents placement of an embodiment of an aortic graftassembly of the invention in the ascending aorta, aortic arch and aportion of the descending aorta of a subject.

FIG. 13 represents zones (0, 1, 2, 3 and 4) of the aorta and majorvessels branching from the aorta (prior art).

FIG. 14 represents zones (0, 1, 2, 3 and 4) of the aorta, an aorticaneurysm, a right carotid artery to left carotid artery bypass, a leftcarotid artery to left subclavian artery bypass and ligation of the leftcarotid and left subclavian arteries (prior art).

FIG. 15 represents zones (0, 1, 2, 3 and 4) of the aorta, an aorticaneurysm, a left carotid artery to left subclavian artery bypass andligation of the left subclavian artery (prior art).

FIGS. 16A-16F are a representation of one embodiment of an aorticassembly system of the invention of one embodiment of a delivery systemof the invention.

FIGS. 17A-17C are side, cross-sectional and perspective views of oneembodiment of the invention, respectively.

FIG. 18 is a perspective view of a nose cone, and inner sheath tuckedinto a proximal cavity of the nose cone of one embodiment of theinvention.

FIGS. 19A and 19B represent alterative embodiments of an inner sheath ofan embodiment of a delivery system of the invention.

FIG. 20 represents an alterative embodiment of an inner sheath of anembodiment of a delivery system of the invention.

FIGS. 21A and 21B represent additional alterative embodiments of aninner sheath of an embodiment of a delivery system of the invention.

FIG. 22 represents an embodiment of a portion of a delivery systememployed by the invention.

FIGS. 23A-23D represent additional views of an aortic assembly systemand branch graft of the invention.

FIGS. 24A-24E represent method steps of one embodiment of a method ofthe invention.

FIGS. 25A and 25B represent alterative embodiments of an inner sheathcomponent of one embodiment of the invention.

FIGS. 26A-26C represent method steps of one embodiment of an alternativemethod of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The features and other details of the invention, either as steps of theinvention or as combinations of parts of the invention will now be moreparticularly described and pointed out in the claims. It will beunderstood that the particular embodiments of the invention are shown byway of illustration and not as limitations of the invention. Theprinciple features of this invention can be employed in variousembodiments without departing from the scope of the invention.

“Proximal” means, when reference is made to a delivery system or acomponent of a delivery system, such as an apex clasp and a nose cone,closest to the clinician using device. Likewise, “distal” means, whenreference is made to a delivery system or a component of a deliverysystem, such as an apex clasp and a nose cone, away from the clinicianusing the device.

When reference is made to a prosthesis to be delivered, such as anaortic graft assembly, tubular aortic component, tunnel graft, branchgraft and stent, the word “proximal” means that portion of theprosthesis or component of the prosthesis that is towards the heart ofthe patient and “distal” means that portion of the prosthesis orcomponent of the prosthesis that is away from the heart of the patient.For clarity, the word “proximate” means close to as opposed to“proximal” or “distal.”

Aortic graft assemblies of the invention can be implanted, for example,by transfemoral access. Tubular branch components can be implanted, forexample, by supraaortic vessel access (e.g., brachial artery), or bytransfemoral or transapical access.

The invention is generally directed to an aortic graft assembly and amethod for deploying the aortic graft assembly. The invention is alsodirected to methods of implanting at least one tubular branch graft intoa patient and the aortic graft assembly. In one embodiment of the aorticgraft assembly of the invention, represented in FIGS. 1A through FIG.1C, aortic graft assembly 10 includes tubular aortic component 12 havingproximal end 14 and distal end 16 connected by wall 18. Wall 18 defineswall aperture 20 that is between proximal end 14 and distal end 16. Wallaperture 20 has proximal end 22 that extends perpendicular to a majorlongitudinal axis 24 of tubular aortic component 12 when viewedorthogonally to major longitudinal axis 24. Wall aperture 20 alsodefines distal end 26 of wall aperture 20.

Tunnel graft 28, shown, for example, in FIGS. 2A, 2B, 3A, 3B, 4A and 4Bis connected to wall 18 of tubular aortic component 12 and extends fromwall aperture 20 toward proximal end 14 of the tubular aortic component12. Tunnel graft 28 includes proximal end 30 and distal end 32. Distalend 32 of tunnel graft 28 is at wall aperture 20 of tubular aorticcomponent 12.

Referring back to FIGS. 1A-1C, proximal stent 34 supports proximal end14 of tubular aortic component 12. Distal stent 36 supports distal end16 of tubular aortic component 12. Similarly, distal stent 36 can beattached to an interior wall to tubular aortic component 12.

Optionally, radiopaque markers 38 are located along a line parallel tomajor longitudinal axis 24 of tubular aortic component 12. In oneembodiment, radiopaque marker 38 is at a proximal apex of wall aperturedistal stent 50 abutting wall aperture 20. Another radiopaque marker isat a distal apex 48 of proximal stent 34. Further, radiopaque marker 38is at least one of proximal end 14 and distal end 16 of tubular aorticcomponent 12. Also optionally, radiopaque markers 40 extend about thecircumference of wall aperture 20 at tubular aortic component 12.Radiopaque markers 38, 40 can be made of any suitable material such asplatinum, iridium, gold, etc. Examples of radiopaque markers aredescribed in the U.S. Pat. No. 8,062,345 and U.S. Published PatentApplication No.: US 2010/0030255, the entire teachings of which areincorporated herein by reference.

Proximal stent 34 in one embodiment, shown in FIGS. 1A, 1B and 1C,includes proximal apices 46 and distal apices 48. In one embodiment, atleast a portion of distal apices 48 abut proximal end 22 of wallaperture 20. Wall aperture distal stent 50 includes proximal apices 52and distal apices 54, a portion of proximal apices 52 of wall aperturedistal stent 50 abut distal end 26 of wall aperture 20. Clasping stent56 at proximal end 14 of tubular aortic component 12 includes at leasttwo exposed proximal apices 58 proximate to proximate end 14 of tubularaortic component 12. In one embodiment, clasping stent 56 is attached toan interior wall of tubular aortic component 12.

Crown stent 60 is located between clasping stent 56 and proximal end 14of tubular aortic component 12. As can be seen in FIG. 5, at least twosupport wire sutures 62 are located within tubular aortic component 12at proximal end 14 of tubular aortic component 12, distal to proximalapices 58 of clasping stent 56. Support wires sutures 62 are separatedby at least one distal apex 61 of clasping stent 56. In one embodiment,proximal apices 59 of crown stent 60 are blunted, as shown in FIG. 1A.Crown stent 60 and clasping stent 56 can be nested, as shown in FIG. 1A.Crown stent 60 and clasping stent 56 are attached to interior wall 76 oftubular aortic component 12.

At least one stent 64 is located at tubular aortic component 12 betweenproximal stent 34 and distal stent 36. At least a portion of stents 64include proximal apices 66 and distal apices 68 connected by struts 70.At least one partial stent 72 is located at tubular aortic component 12between stents 34, 50 abutting proximal 22 and distal 26 ends of wallaperture 20, respectively, as shown in FIGS. 1B and 1C.

Stents employed in the invention are constructed of a suitable material.In one embodiment, the stents employed by the invention include asuitable shape memory alloy, such as nitinol. Further description ofsuitable materials for construction of stents for use in the inventioncan be found in U.S. Pat. Nos. 7,763,063 and 8,062,345, the teachings ofwhich are incorporated herein by reference in their entirety.

In one embodiment, the arc length of proximal end 22 of wall aperture 20is equal to or less than one-half the circumference of tubular aorticcomponent 12. Examples of suitable arc lengths of proximal end 22 ofwall aperture 20 include arc lengths equal to one member selected fromthe group consisting of about 6 mm, about 8 mm, about 10 mm, about 12 mmor about 14 mm. In one embodiment, a longitudinal length of wallaperture 20 is equal to or less than about 90 mm. In another embodiment,the longitudinal length of wall aperture 20 is equal to or greater thanabout 14 mm.

Referring to FIGS. 2A, 2B, 3A and 3B, the distance between proximal end22 of wall aperture 20 and proximal end 14 of tubular aortic component12 can be in a range of between about 10 mm and about 80 mm. In atypical embodiment, the distance between proximal end 22 of wallaperture 20 and proximal end 14 of tubular aortic component 12 is onemember selected from the group consisting of about 20 mm, about 40 mm,about 60 mm, about 80 mm or about 90 mm. In one embodiment, the distancebetween proximal end 22 of wall aperture 20 and proximal end 12 oftubular aortic component 12 is about 40 mm, as shown in FIGS. 2A and 2B.In another embodiment, the distance between proximal end 22 of wallaperture 20 and proximal end 14 of tubular aortic component 12 is about60 mm, as shown in FIGS. 3A and 3B.

In one embodiment, shown in FIG. 1A, retention component 78 is locatedat tubular aortic component 12 distal to wall aperture 20 and withintubular aortic component 12 (only external portion of retentioncomponent 78 is shown in FIG. 1A). In one embodiment, retentioncomponent is a suture loop. In another embodiment, retention component78 is at least one of a magnet or a stent apex. In still anotherembodiment, retention component 78 is radiopaque. In one embodiment,retention component 78 is at a proximal apex 52 of stent 50 abuttingdistal end 26 of wall aperture 20.

In another embodiment, shown in FIG. 6, circumferential stent 80 islocated at tubular aortic component 12 and surrounds wall aperture 20.In one embodiment, a circumferential stent 80 surrounding wall aperture20 defines, at least in part, wall aperture 20. In one embodiment, thediameter of proximal end 14 of tubular aortic component 12 is greaterthan the diameter of distal end 16 of tubular aortic component 12, asshown in FIG. 1B.

In one embodiment, shown in FIGS. 7A, 8A, 9A and 10A, the interfacebetween tubular aortic component 12 and wall aperture 20, when viewedorthogonally to major longitudinal axis 24 of tubular aortic component12 is a polygon, such as is shown in the referenced figures, a polygonhaving four sides. In various embodiments, the polygon can be a square,a rectangle, a parallelogram, or a rhombus (not shown).

In a specific embodiment, inferior portion 83 is on one side of tubularaortic component 12 opposite wall aperture 20 and is essentiallyparallel to major longitudinal axis 24 of tubular aortic component 12,shown in FIG. 1B. Exposed apices 58 of clasping stent 56, when collapsedwill cause at least partial collapse of proximal end 14 of tubularaortic component 12 at clasping stent 56, as can be seen in FIG. 11. Atleast one of support wire sutures 62 are at inferior portion 83 withintubular aortic component 12. In a specific embodiment, support wiresutures 62 are at apices of clasping stent 56. Preferably, support wiresutures 62 are separated by at least one proximal apex of claspingstent.

In one embodiment, distal end 32 of tunnel graft 28 has a diametergreater than that of proximal end 30 of tunnel graft 28, as can be seenin FIGS. 2A and 3A. In another embodiment, proximal end 30 of tunnelgraft 28 is between the most proximal edge of proximal end 14 of tubularaortic component 12 and proximal end 22 of wall aperture 20, as shown inFIGS. 2A, 2B, 3A, 3B, 4A and 4B. As shown in FIGS. 4A and 4B, tunnelgraft 28 is secured to an interior wall of tubular aortic component 12by a suitable means, such as by sutures 29.

As can be seen in FIGS. 1B, 1C, 2A, 2B, 3A and 3B, tunnel graft 28includes open portion 84 at wall aperture 20. Tubular portion 86 extendsproximally from open portion 84, as shown in FIGS. 2A, 2B, 3A and 3B. Inone embodiment, tubular portion includes stents 88, 90 at each of aproximal 92 and distal end 94 of tubular portion 86, as shown in FIGS.2B and 3B. Preferably, stents 88, 90 at proximal 92 and distal 94 endsof tubular portion 86 includes proximal and distal apices connected bystruts. Preferably, stent 88 at proximal end 92 of tubular portion 86includes at least one barb 96 (FIG. 2B). In another embodiment shown inFIG. 3B, barbs 96 extend for distal apices of stent 98 of tubularportion 86. Optionally, tubular portion 86 further includes at least onestent 98 between stents 88, 90 at proximal 92 and distal 94 ends,respectively, of tubular portion 86. Preferably, at least one of stents98 between stents 88, 90 at proximal end 92 and distal end 94 includesat least one barb. Most preferably, stents of tubular portion 86 includenitinol.

As can also be seen in FIGS. 2A and 2B and 3A and 3B, 4A and 4B, distalend 94 of tubular portion 86 is generally conical, whereby distal end 94of tubular portion 86 essentially matches proximal end 92 of tunnelgraft 28 at proximal end 22 of wall aperture 20, as a continuum or,optionally, at a seam, not shown. In one embodiment, a maximum diameterof proximal end of tunnel graft 28 is equal to or less than the diameterof distal end of tubular portion 94. Examples of suitable maximumdiameters of proximal end 30 of tunnel graft 28 include, for example,diameters equal to or greater than a diameter selected from the groupconsisting of about 6 mm, about 8 mm, about 10 mm, about 12 mm or about14 mm.

Preferably, tubular portion 86 has a major longitudinal axis that isparallel to major longitudinal axis 24 of tubular aortic component 12.Proximal end 92 of tubular portion 86 is distal to the most proximaledge of proximal end 14 of tubular aortic component 12. In oneembodiment, not shown, proximal end 92 of tubular portion 86 iscoterminous with the most proximal edge of proximal end 14 of tubularaortic component 12 or, alternatively, as shown in FIGS. 2A and 2B and3A and 3B, 4A and 4B, is distal to proximal end 14 of tubular aorticcomponent 12. In another embodiment, tubular portion 86 has a major axisat an angle A 81 relative to major longitudinal axis 24 of tubularaortic component 12, as shown in FIG. 9A. In one embodiment, the angleis in the range of at least one of between about 0° and about 90°, suchas 10°, 20°, 30°, 45°, 60°, and 90° C.

Further, as shown in FIGS. 9A and 9B, proximal end 92 of tubular portion86 has geometric center 150 that is distinct from a geometric center 152of tubular aortic component 12, wherein line 154 defined by geometriccenter 150 of proximal end 92 of tubular portion 86 and geometric center152 of tubular aortic component 12 in a plane defined by proximal end 92of tubular portion 86, taken along line 9 B of FIG. 9A, is at a positiveangle B from line 156 defined by geometric center 152 of tubular aorticcomponent 12 and point 158 along centerline 160 bisecting wall aperture20 and parallel to major longitudinal axis 24 (FIG. 1A) of tubularaortic component 12, point 158 being in the same plane as the geometriccenters 150, 152 of proximal end 92 of tubular portion 86 and tubularaortic component 12, respectively. Examples of suitable positive anglesB can be at least one member selected for the group consisting of ±10°,±20°, ±30°, ±45°, ±60°, ±90°, ±120°, ±135°, ±160°, ±170° and 180°.

In one embodiment, at least one radiopaque marker 99 is located at atleast one of proximal end 92 of tunnel graft 28 and distal end 94 oftubular portion 86 of tunnel graft 28, as shown in FIGS. 2B, 3B and 4B.Another embodiment includes tubular portion 100 and further includessecond tubular portion 102 of tunnel graft 28 extending proximal to openportion 84 of the tunnel graft 28, wherein second tubular portion 102has distal end 104 and proximal end 106 as shown in FIGS. 7A, 7B, 8A and8B. In one embodiment, not shown, second tubular portion 102 is ofunequal length to that of first tubular portion 100. In anotherembodiment, shown in FIGS. 7A and 7B, second tubular portion 102 isparallel to first tubular portion 100. First tubular portion 100 andsecond tubular portion 102 are each a distinct, and integrally completetubular portion. In another embodiment, shown in FIGS. 8A and 8B,tubular portions share common wall of a first graft material 108 thatpartition a conduit of the second graft material 110. In thisembodiment, first 108 and second 110 graft materials define, at least inpart, first tubular portion 100 and second tubular portion 102. As shownin FIGS. 10A and 10B, tubular portions 112 and 114 extend away from eachother and proximally from open portion 84.

In still another embodiment, shown in FIGS. 2A, 2B, 3A, 3B, 4A and 4B,proximal end 92 of tunnel graft 28 has a diameter in a range betweenabout 5 mm and about 10 mm, or between about 5 mm and about 15 mm, orbetween about 8 mm and about 15 mm. Generally, tubular portion 86 has alength in a range of between about 20 mm and about 60 mm, or betweenabout 20 mm and about 100 mm. Most commonly, tubular portion 86 has alength in a range between about 30 and 50 mm. Preferably, proximal end92 of tunnel graft 28 is within at least about 5 mm, about 10 mm, andabout 15 mm or about 20 mm of proximal end 14 of tubular aorticcomponent 12.

FIG. 12 shows one embodiment of aortic graft assembly 10 of theinvention fully deployed within aorta 117 of a patient. FIGS. 13-15 showvarious stages of an aortic bypass operation (prior art).

As shown, in FIGS. 16A-16F, aortic graft assembly 200 (FIG. 16A)includes delivery component 202 (FIG. 16B) to which tubular aorticcomponent 12 (FIG. 16A) is attached (FIGS. 16A and 16C). Deliverycomponent 202 includes control catheter 204 (FIG. 16B), about whichtubular aortic component 12 (FIG. 16C) extends, nose cone 206 (FIGS. 16Band 16C) is fixed at a distal end of control catheter 204 (FIGS. 17A and17B).

In one embodiment, shown in FIGS. 17A, 17B and 17C, delivery component202 further includes inner sheath 210 extending about control catheter204. A distal opening at distal end 214 of inner sheath 210, can betucked into nose cone 206 (FIGS. 17A, 17B and 18). In still anotherembodiment, shown in FIGS. 19A and 19B, inner sheath 210 includesinferior portion 82, said inferior portion 82 having fluted portion 85as can be seen in FIG. 20. Optionally, as can be seen in FIGS. 21A and21B, inner sheath 210 can be tapered to narrow toward distal end 211 orof essentially constant diameter. In one embodiment, inner sheath 210defines at least one through hole 280 at proximal end 282 of innersheath 210, as shown in FIGS. 25A and 25B.

As can be seen in FIGS. 17A and 17B, introducer sheath 216 extends aboutinner sheath 210 and about tubular aortic component 12, whereinintroducer sheath 216 is retractable relative to inner sheath 210 tothereby release distal end 214 of inner sheath 210. Nose cone 206 canthereafter be retracted within inner sheath 210.

Delivery component 202, shown in FIGS. 17A, 17B, 17C and 22, furtherincludes at least one supporting wire 230 fixed at proximal end 224 tosupport base 235, substantially parallel to a major longitudinal axis ofouter control tube 232 and free at the distal end 228, wherein free end228 of at least one of supporting wire 230 and internal sutures 62 (FIG.17B) at the proximal end 14 of tubular aortic component 12 releasablysecures proximal end 14 of tubular aortic component 12 to at least oneof supporting wires 230. Outer control tube 232 is slidable alongcontrol catheter 204. Supporting wires 230 are fixed at proximal ends224 to support base 235 at outer control tube 232 distal to proximalapex clasp 240. Free ends 228 of support wires 230 are proximate toproximal end 14 and to nose cone 206. Proximal portion 252 of distalapex clasp 238 and outer control tube 232 are slidable along the controlcatheter 204 with movement of outer control tube 232 (FIGS. 16B and 22).Distal apex clasp 238 fixes proximal end 14 of tubular aortic component12 by securing exposed apices 58 (FIG. 16C) of clasping stent 56 atproximal end 14 of tubular aortic component 12. As shown in FIG. 16B,distal portion 248 of distal apex clasp 238 mates with of teeth 252 ofproximal portion 250 of distal apex clasp 238 in a closed position thatsecures exposed apices 58 of clasping stent 56 of tubular aorticcomponent 12.

Proximal apex clasp 240 is at outer control tube 232 (FIG. 17B).Proximal apex clasp 240 includes teeth 246 (FIG. 16B) extending distallyfrom proximal portion 244 of proximal clasp 240. Teeth 246 extenddistally through retention component 78 of tubular aortic component 12,as shown in FIG. 17B.

As shown in FIGS. 23A-23D, tubular branch component 254 includesproximal end 256 and distal end 258, wherein proximal end 256 of tubularbranch component 254 is configured to engage proximal end 30 of tunnelgraft 28. In an embodiment, the engagement is by interfering relationbetween tubular branch component 254 and tunnel graft 28. When aorticgraft assembly 10 is implanted in the aorta of a patient, a seal formswith at least one member of the group consisting of the proximal end ofat least one of the tubular aortic component 12, tubular branchcomponent 254 and second tubular branch component 260, and the distalend of at least one of tubular aortic component 12, tubular branchcomponent 254 and second tubular component 260. A “seal” as definedherein, means that essentially no fluid will seep between the wall of afirst conduit and the wall of a second conduit within which the firstconduit is located. Such seals typically will be at the most proximalportion of a juncture between nested first and second conduits.

In one embodiment, supporting wire 230 has at least one stop 274 (FIG.11), wherein stop 274 limits movement of suture loop 62 along supportingwire 230.

In another embodiment, tubular aortic component 12 includes radiopaquesutures 18 and inner sheath 210 includes radiopaque markers 276, all ofwhich are longitudinally aligned along a path of relative movement ofinner sheath 210 (FIGS. 16A-16F and 17A-17C) and tubular aorticcomponent 12 during deployment of tubular aortic component 12, and arespaced apart from each other, whereby partial retraction of inner sheath210 will cause overlap of radiopaque markers 276 with radiopaque markers38. In one embodiment, radiopaque markers 38 are also, or alternatively,on superior portions of inner sheath 210 and tubular aortic component12. Preferably, radiopaque markers 38, 276 are asymmetric, wherein ashape of radiopaque markers 38, 276 changes as radiopaque markers 38,276 are aligned with a surgical site. Preferably, radiopaque markers 38,276 of tubular aortic component 12 are elongated and are substantiallyaligned with the major longitudinal axis 24 of inner sheath 210.

In a preferred embodiment, referring back to FIGS. 16A-16F and 17A-17C,tubular aortic component 12 is further constrained at at least one endby a clasp, such as distal apex clasp 238 or proximal apex clasp 240,and the method includes the step of releasing the clasp with retractionof supporting wire 230 from suture loop 62 of tubular aortic component12. In this embodiment, preferably, tubular aortic component 12 furtherincludes at least one radiopaque marker 38, wherein, preferably,radiopaque marker 38 is located on tubular aortic component 12 facingaway from cavity 284 (FIG. 18) of the curve 286 (FIG. 18) defined bycontrol catheter 204. Preferably, inner sheath 210 further includes atleast one radiopaque marker 276, wherein radiopaque marker 276 of innersheath 210 overlaps at least one radiopaque marker 276 of tubular aorticcomponent 12 when tubular aortic component 12 is partially deployed. Instill another embodiment, tubular aortic component 12 is furtherconstrained by proximal clasp 240 and proximal fixed end 234 ofsupporting wire 230.

A method for implanting a prosthesis of the invention includes the stepsof delivering tubular aortic component 12 within introducer sheath 216along guidewire 320 through an aorta 262 to aneurysm 270 of the patient,shown in FIGS. 24A-24E. Tubular aortic component 12 is radiallyconstrained and supported at least in part by control catheter 204(FIGS. 16B, 16C, 16D), which is slidable along guidewire 320 (FIGS.24A-24E). As shown in FIGS. 16A-16F and 17A-17C, tubular aorticcomponent 12 is further longitudinally constrained by at least onesupporting wire 230 extending from support base 235 at outer controltube 232 extending about and slidable along control catheter 204. Freeend 228 of at least one of supporting wire 230 is arcuate and extendsthrough suture loop 62 (FIG. 17B), within proximal end 14 of tubularaortic component 12.

Referring back to FIGS. 24A-24E, tubular aortic component 12 is guidedto aneurysm 270 along guidewire 320. Inner sheath 210 (FIG. 17B), ispartially retracted from tubular aortic component 12, whereby supportingwire 230 at least partially restricts longitudinal movement of proximalend 14 of tubular aortic component 12 until proximal end 14 of tubularaortic component 12 is secure within aorta 262 (FIGS. 24A-24E) of thepatient to thereby prevent collapse of proximal end 14 of tubular aorticcomponent 12 at an inferior portion 264 of aorta 262.

In one embodiment, inner sheath 210 is releasably secured at distal end214 within a cavity defined by the proximal end of nose cone 206 (FIG.18). In this embodiment, as shown in FIGS. 24A-24E, optional innersheath 210 is partially retracted to release the distal end of the innersheath 210 from nose cone 206 and thereby cause partial expansion oftubular aortic component 12. Wall aperture 20 is aligned over at leastone vessel ostium 290, 292, 294 at aneurysm site 263 of the patient.Optionally, in embodiments of the invention that employ inner sheath210, inner sheath 210 is then partially retracted to expose the proximalend 14 of tubular aortic component 12, including crown stent 56 and theclasping stent 60 (FIG. 1A). Control tube 232 is then partially extendedto release bare apices 58 (FIG. 1A) of clasping stent 56 from distalclasp 238 and to release retention component 78 from proximal clasp 240(FIGS. 16B and 17B), while retaining suture loops 62 on ends 228 ofsupport wires 230 (FIGS. 16A-16F and 17A-17C). Nose cone 206 is thenpartially retracted into proximal end of tubular aortic component 12 andthe delivery assembly and tubular aortic component 12 are then advancedto a final position within aorta 262 spanning aneurysm 263 of thepatient. Control tube 232 is then further retracted to release sutureloops 62 from ends 228 of support wires 230 Inner sheath 210 is thenfully retracted (in embodiments of the invention that employ innersheath 210) and then nose cone 206 and supporting wires 230 are fullyretracted to complete deployment of tubular aortic component 12.

In an embodiment, the method of the invention includes the step ofimplanting at least one tubular branch component 254 in at least one ofan innominate artery (also referred to as “brachiocephalic artery”) 290,a left subclavian artery 292, a left common carotid artery 294, or rightcommon carotid artery 296 of the patient into wall aperture 20 andtunnel graft 28 within tubular aortic component 12, as shown, withrespect to the prior art, in FIGS. 13-15, and in FIGS. 24A-24E. In apreferred embodiment, the method of the invention includes the steps ofimplanting tubular branch component 254 into innominate artery 290, andanother tubular branch component, into the left common carotid artery294 (FIG. 24E).

Implantation of the aortic graft assemblies of the invention can includeimplantation in at least one of a portion of the ascending aorta, theaortic arch, the descending aorta and abdominal aorta (see FIGS. 12,24A-24E and 26A-26C). Implantation near, around or at the arch of theaorta, can include a right common carotid to left common carotid arterybypass with ligation of the left common carotid inferior to the point ofthe bypass and a left common carotid artery to left subclavian arterybypass with ligation inferior to the bypass. In another embodiment, forexample, an aortic graft assembly of the invention that includes twotubular branch components (e.g., one into the right common carotid,another into the left common carotid) can include a left common carotidartery to left subclavian artery bypass, with ligation of the leftsubclavian artery inferior to the bypass (see FIGS. 16 and 17).Alternatively, as shown in FIGS. 26A-26C, aortic assembly systems can beimplanted in the abdominal aorta 300. Opening 84 can be placed inabdominal aorta proximate to celiac artery 302, superior mesentericartery 304 or renal artery 306, thereby spanning aneurysm 308. Tubularbranch component 254 can then be implanted into at least one of celiacartery 302, superior mesenteric artery 304 or at least one renal artery306.

In another embodiment, shown in FIGS. 25A and 25B, inner sheath 210about tubular aortic component 12, includes proximal perforated portion280 that defines through-holes 282. Through-holes 282 can be defined bya mesh or fabric of perforation portion 280, as shown in FIG. 25A, or asdistinct openings, such as longitudinal through-hole opening 284 shownin FIG. 25B. The through-holes permit relatively continuous blood flowduring implantation of the prosthesis, as further described in U.S.Published Patent Application No.: 2010/0234932, the teachings of whichare incorporated herein by reference in their entirety.

Suitable systems, delivery devices and components of systems, stentgrafts as described in U.S. application No. 11/449,337, filed on Jun. 8,2006; Ser. No. 11/699,700, filed on Jan. 30, 2007; Ser. No. 11/700,609,filed on Jan. 31, 2007; Ser. No. 11/701,867, filed on Feb. 1, 2007; Ser.No. 11/828,653, filed on Jul. 26, 2007; Ser. No. 12/137,592, filed onJun. 12, 2008; Ser. No. 11/701,876, filed on Feb. 1, 2007; 61/164,545,filed on Mar. 30, 2009; Ser. No. 12/459,387, filed on Jun. 30, 2009; andU.S. Pat. Nos. 7,763,063; 8,007,605; 8,062,345; 8,062,349; 8,070,790;8,292,943 and 8,308,790, the teachings of all of which are herebyincorporated by reference in their entirety, can be employed to deliverthe aortic graft assembly of the invention by the method of theinvention.

The teachings of all patents, published applications and referencescited herein are incorporated by reference in their entirety.

EXAMPLE 1

A 74 year old male with penetrating atherosclerotic ulcer (PAU) of theaorta located on the interior side of the thoracic arch at the level ofthe left common carotid was treated. A model of the patient's anatomywas made based on computer tomography (CT) scanning A right carotid toleft carotid bypass was performed initially without ligating the leftcarotid. A tubular aortic component of an aortic graft assembly (46mm−42 mm×80 mm) was deployed at the sinotubular junction. The ascendingaorta of this patent had a graft diameter of about 44 mm. A tubularaortic component having a diameter of 46/42 mm×80 mm was employed toprovide a smaller healthy neck. The proximal end of the tubular aorticcomponent of the aortic graft assembly was released to optimizeapposition with the wall of the ascending aorta.

A tunnel graft (46 mm−34 mm×220 mm) was used in the aortic graftassembly. The tunnel graft was 15 mm in diameter. The aperture of thetubular aortic component was 30 mm×30 mm. A graft of a size of 15 mm−17mm×100 mm or 15 mm−17 mm×110 mm) was employed to bridge the graft tunnelwith the brachial cephalic trunk and a wire-catheter was positionedprior to implantation as a precautionary bailout. An angiogram wasperformed to confirm profusion to the and left common carotid arteries.The tunnel graft was advanced to the proximal portion of the aperture ofthe tubular aortic component with the distal end of at least one tubularbranch component. The graft was aligned to allow canulation of thetunnel graft through the innominate or the left common carotid arteriesbased on movement of the tubular aortic component. The tunnel graft wascanulated via the right common carotid. A relatively short tubularbranch component was selected in this patient because the tunnel graftwas deployed more distally. The distal end of the branch graft wasaligned with the brachial cephalic trunk bifurcation and the tubularbranch graft deployed without complication. An angiogram showedexclusion of the aneurysm with flow to the innominate artery and leftcommon carotid artery via a carotid-carotid bypass.

EXAMPLE 2

An 81 year old male with an aneurysm at the arch of the aorta wastreated. A CT scan was employed to model the patient's anatomy. Thethoracic aneurysm was in a region of the aortic arch and at least aportion of the descending aorta. The tunnel graft had a diameter ofabout 15 mm.

While this invention has been particularly shown and described withreferences to example embodiments thereof, it will be understood bythose skilled in the art that various changes in form and details may bemade therein without departing from the scope of the inventionencompassed by the appended claims.

What is claimed is:
 1. An aortic graft assembly, comprising: a) atubular aortic component that includes a proximal end and a distal endconnected by a wall of the tubular aortic component, the wall defining awall aperture that is between the proximal and distal ends, the wallaperture having a proximal end and a distal end, the proximal end of thewall aperture extending perpendicular to a major longitudinal axis ofthe tubular aortic component when viewed orthogonally to the majorlongitudinal axis; b) a tunnel graft connected to the wall of thetubular aortic component and extending from the wall aperture toward theproximal end of the tubular aortic component, the tunnel graft having aproximal end and a distal end, the distal end being at the wall apertureof the tubular aortic component; c) a proximal stent that supports theproximal end of the tubular aortic component; and d) a distal stent thatsupports the distal end of the tubular aortic component.
 2. The aorticgraft assembly of claim 1, further including a clasping stent at theproximal end of the tubular aortic component, the clasping stentincluding at least two exposed proximal apices proximate to the proximalend of tubular component.
 3. The aortic graft assembly of claim 2,wherein the clasping stent is attached to an interior wall of thetubular aortic component.
 4. The aortic graft assembly of claim 3,wherein the tubular aortic component includes a centerline that bisectsthe wall aperture and two of the exposed proximal apices of the claspingstent are adjacent to the centerline, whereby collapse of the unattachedapices will cause at least partial collapse of the tubular aorticcomponent at the clasping stent.
 5. The aortic graft assembly of claim2, further including a crown stent between the clasping stent and theproximal end of the tubular aortic component.
 6. The aortic graftassembly of claim 5, wherein the crown stent includes proximal anddistal apices connected by struts.
 7. The aortic graft assembly of claim6, wherein the proximal apices of the crown stent are blunted relativeto the distal apices of the crown stent.
 8. The aortic graft assembly ofclaim 7, wherein the clasping and crown stents are nested with eachother.
 9. The aortic graft assembly of claim 8, wherein the crown stentis attached to an interior surface of the tubular aortic component. 10.The aortic graft assembly of claim 1, further including at least onestent between the proximal and distal stents wherein at least a portionof said stent includes alternating proximal and distal apices connectedby struts.
 11. The aortic graft assembly of claim 1, further includingat least two support wire sutures within the tubular aortic component atthe proximal end of the tubular aortic component.
 12. The aortic graftassembly of claim 11, wherein at least one of the support wire suturesare at an inferior portion within the tubular aortic component.
 13. Theaortic graft assembly of claim 12, wherein the support wire sutures aredistal to proximal apices of the clasping stent.
 14. The aortic graftassembly of claim 13, wherein the support wire sutures are separated byat least one distal apex of the proximal clasping stent.
 15. The aorticgraft assembly of claim 1, wherein the length of the proximal end of thewall aperture transverse to a major longitudinal axis of the tubularaortic component is equal to or less than one-half the circumference ofthe tubular aortic component.
 16. The aortic graft assembly of claim 15,wherein the length of the proximal end of the wall aperture is about 6mm, about 8 mm, about 10 mm, about 12 mm or about 14 mm.
 17. The aorticgraft assembly of claim 15, wherein a longitudinal length of the wallaperture is equal to or less than about 90 mm.
 18. A method forimplanting a prosthesis, comprising the steps of: a) delivering atubular aortic component defining a wall aperture through an aorta to ananeurysm site of a patient, the tubular aortic component being radiallyand releasably constrained by a distal clasp at a distal end of an outercontrol tube of a delivery device, and releasably attached by aretention component to a proximal clasp at the outer control tubeproximal to the proximal clasp, the tubular aortic component furthersupported by a control catheter of the delivery device extending withinthe outer control tube; b) aligning the wall aperture over at least onevessel ostium at the aneurysm site of the patient; and c) retracting theouter control tube, thereby releasing the tubular aortic component fromthe distal and proximal clasps, thereby deploying the tubular aorticcomponent at the aneurysm site in the patient.
 19. An aortic graftassembly, comprising: a) a tubular aortic component that includes aproximal end and a distal end connected by a wall of the tubular aorticcomponent, the wall defining a wall aperture that is between theproximal and distal ends, the wall aperture having a proximal end and adistal end, the proximal end of the wall aperture extendingperpendicular to a major longitudinal axis of the tubular aorticcomponent when viewed orthogonally to the major longitudinal axis; b) atunnel graft connected to the wall of the tubular aortic component andextending from the wall aperture toward the proximal end of the tubularaortic component, the tunnel graft having a proximal end and a distalend, the distal end being at the wall aperture of the tubular aorticcomponent; c) a proximal stent that supports the proximal end of thetubular aortic component; d) a distal stent that supports the distal endof the tubular aortic component; e) a clasping stent at the proximal endof the tubular aortic component, the clasping stent including at leasttwo exposed proximal apices proximate to the proximal end of tubularcomponent and attached to an interior wall of the tubular aorticcomponent; and f) a crown stent between the clasping stent and theproximal end of the tubular aortic component, the crown stent attachedto an interior surface of the tubular aortic component.
 20. An aorticgraft assembly, comprising: a) a tubular aortic component that includesa proximal end and a distal end connected by a wall of the tubularaortic component, the wall defining a wall aperture that is between theproximal and distal ends, the wall aperture having a proximal end and adistal end, the proximal end of the wall aperture extendingperpendicular to a major longitudinal axis of the tubular aorticcomponent when viewed orthogonally to the major longitudinal axis; b) atunnel graft connected to the wall of the tubular aortic component andextending from the wall aperture toward the proximal end of the tubularaortic component, the tunnel graft having a proximal end and a distalend, the distal end being at the wall aperture of the tubular aorticcomponent; c) a proximal stent that abuts the proximal end of thetubular aortic component; d) a distal stent that supports the distal endof the tubular aortic component; e) an abutting distal stent thatincludes at least one proximal apex that abut the distal end of the wallaperture; f) a clasping stent at the proximal end of the tubular aorticcomponent, the clasping stent including at least two exposed proximalapices proximate to the proximal end of tubular component and attachedto an interior wall of the tubular aortic component; and g) a crownstent between the clasping stent and the proximal end of the tubularaortic component, the crown stent attached to an interior surface of thetubular aortic component.